Patent SG-11201807824U-A (SG)
Title: Methods for continuously inactivating a virus during manufacture of a protein
Inventor: FIADEIRO MARCUS ANDRE
IPC: C07K16/00
Filed: 2017-03-10
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property -, Organization 111111110111101110101011111010111110111011111011011101110111101111101111011111 International Bureau 0.. .... .. ..... ..or::,„, (10) International Publication Number (43) International Publication Date WO 2017/156355 Al 14 September 2017 (14.09.2017) WIP0 I PCT (51) International Patent Classification: (74) Agents: DATLOW, Philip I. et al.; Boehringer Ingelheim C07K 16/00 (2006.01) Pharmaceuticals, Inc., 900 Ridgebury Road, P.O. Box 368, Ridgefield, CT 06877-0368 (US). (21) International Application Number: PCT/US2017/021714 (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (22) International Filing Date: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, 10 March 2017 (10.03.2017) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, (25) Filing Language: English DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, (26) Publication Language: English KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, (30) Priority Data: MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, 62/307,287 11 March 2016 (11.03.2016) US NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, (71) Applicant: BOEHRINGER INGELHEIM INTERNA- TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, TIONAL GMBH [DE/DE]; Boehringer Ingelheim GmbH, ZA, ZM, ZW. Corporate Patents, Binger Strasse 173, 55216 Ingelheim am Rhein (DE). (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (72) Inventors (for US only): FIADEIRO, Marcus Andre; c/o GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, VP, IP Legal, Boehringer Ingelheim USA Corp., 900 TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, Ridgebury Rd., P.O. Box 368, Ridgefield, Connecticut TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 06877-0368 (US). COFFMAN, Jonathan; c/o VP, IP DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, — Legal, Boehringer Ingelheim USA Corp., 900 Ridgebury LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, _ Rd., P.O. Box 368, Ridgefield, Connecticut 06877-0368 SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, (US). FAHRNER, Robert Lee; c/o VP, IP Legal, GW, KM, ML, MR, NE, SN, TD, TG). = Boehringer Ingelheim USA Corp., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, Connecticut 06877-0368 (US). Declarations under Rule 4.17: KUBLBECK, Jill Ann; c/o VP, IP Legal, Boehringer In- — as to applicant's entitlement to apply for and be a granted USA Corp., 900 Ridgebury Rd., P.O. Box 368, 4.17(ii)) gelheim patent (Rule Ridgefield, Connecticut 06877-0368 (US). OROZCO, — Published: Raquel; c/o VP, IP Legal, Boehringer Ingelheim USA = Corp., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, Con- — with international search report (Art. 21(3)) 06877-0368 (US). SALM, Jeffrey Richard; necticut c/o VP, IP, Legal, Boehringer Ingelheim USA Corp., 900 Ridgebury Road, PO Box 368, Ridgefield, Connecticut = 06877-0368 (US). = = = = = = 1-1 11 in 11 in f.r) (54) Title: METHODS FOR CONTINUOUSLY INACTIVATING A VIRUS DURING MANUFACTURE OF A PROTEIN , tD L I ) (57) : Methods for continuously inactivating a virus during manufacture of a protein are provided. Steps include (1) com- S biasing, at a single predetermined volumetric ratio, a composition including the protein, and a composition including a virus-inactiva- tion reagent, to obtain a treatment composition having a predetermined property for inactivation of a virus; (2) transferring the treat - I-1 c:::: ) ment composition to a treatment vessel; (3) incubating the treatment composition in the treatment vessel at predetermined condi - ei tions; and (4) subjecting the treatment composition to a post-treatment processing operation. The single predetermined volumetric O ratio has been selected to ensure that the predetermined property of the treatment composition is maintained across a range of con- centrations predicted for the protein in the composition including the protein. Steps (1) to (3) are carried out (a) continuously and (b) without feedback control being exerted by either adjustment of the volumetric ratio or diversion of the treatment composition.